Identity
- Trade Name
- Patient Interface 125 Kit EUDAMEDFDA UDI
- Generic Name
- Laser beam delivery unit holder FDA UDI
- Device Name
- Patient Interface 125 Kit EUDAMED
- Model / Reference
- 90000145 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 04050555002086 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04050555002086 EUDAMED
- FDA Product Code
- OOE FDA UDI
- EMDN Code
- Z12011085 LASER SURGERY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Laser beam delivery unit holder FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 886.4390 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Varicose vein lasing procedure kit
Patient Interface 125 Kit by Technolas Perfect Vision GmbH — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Varicose vein lasing procedure kit.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-04050555002086 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Technolas Perfect Vision GmbH
- EUDAMED SRN
- DE-MF-000007094
Sources (2)
- EUDAMED 73fbb84b-7b90-4ef9-91be-496e557d21fc 61 fields · synced Jul 21, 2026
- FDA UDI 97276500-8533-4278-86d9-68cd046dfa52 32 fields · synced May 30, 2026